The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for Watchchild Obsterical Patient Data Management System.
| Device ID | K974248 |
| 510k Number | K974248 |
| Device Name: | WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM |
| Classification | System, Monitoring, Perinatal |
| Applicant | AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Contact | Marci L Goldfinger |
| Correspondent | Marci L Goldfinger AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-12 |
| Decision Date | 1998-10-07 |
| Summary: | summary |